QC Validation Chemist

The Validation Chemist is responsible for executing validation, verification, and compliance-related activities to ensure laboratory operations meet regulatory, accreditation, and internal quality requirements. This role supports method lifecycle management, data integrity initiatives, investigation activities, audit readiness, and continuous improvement projects. The Validation Chemist works closely with Quality Control, Quality Assurance, and laboratory personnel to maintain compliance while improving efficiency and reliability of analytical processes.

• Bachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Minimum 2+ years of laboratory experience in a regulated environment preferred.
• Demonstrated experience with analytical method validation, method verification, and laboratory investigations preferred.
• Experience working in a regulated laboratory environment.
• Strong understanding of analytical chemistry principles and laboratory investigations.
• Proficiency with Microsoft Office applications.

• Advanced degree in Chemistry or related scientific discipline.
• Experience supporting ISO/IEC 17025 accredited laboratories.
• Experience in pharmaceutical, nutraceutical, dietary supplement, cannabis, food, or biotechnology industries.
• Experience implementing new analytical technologies and instrumentation.
• Experience with laboratory information management systems (LIMS).
• Experience of participating in regulatory inspections and accreditation audits.

• Strong working knowledge of: HPLC, GC, ICP-MS HPTLC, UV/VIS and Method Validation and Verification Principles
• Familiarity with: ISO/IEC 17025, cGMP Requirements, USP, AOAC, ICH Guidelines

• Strong understanding of analytical laboratory practices and quality systems.
• Knowledge of OOS investigations, CAPA processes, and data integrity principles.
• Excellent documentation, organizational, and problem-solving skills.
• Ability to manage multiple projects and priorities simultaneously.
• Effective verbal and written communication skills.
• Proficiency with laboratory software, LIMS, and Microsoft Office applications.

• Execute analytical method validation and verification studies in accordance with approved protocols, applicable regulations, and internal procedures.
• Review and document validation and verification results to ensure compliance with quality standards.
• Support remediation efforts and reduction of validation backlogs through timely execution of assigned projects.
• Assist in the development, revision, and implementation of validation protocols and reports.

• Perform compliance-related activities to support adherence to GMP, GLP, ISO, and applicable regulatory requirements.
• Participate in data integrity reviews and assessments to ensure accuracy, completeness, consistency, and traceability of laboratory data.
• Support implementation and monitoring of corrective and preventive actions (CAPA) resulting from investigations, audits, and compliance assessments.
• Maintain accurate and complete documentation in accordance with Good Documentation Practices (GDP).

• Support laboratory investigations, including Out‑Specification (OOS), Out‑Trend (OOT), deviations, and non‑conformances.
• Assist with root cause analysis and the development of effective corrective actions.
• Contribute to continuous improvement initiatives aimed at enhancing laboratory efficiency, compliance, and data quality.
• Identify opportunities to improve processes, procedures,…